A 16 Week Evaluation of the Novartis Health Management Tool (HMT) in Age Related Macular Degeneration (AMD)

A 16 Week Evaluation of the Novartis Health Management Tool in Assessing Self-test Visual Function in Patients With AMD Treated With Ranibizumab

This is a prospective pilot study to evaluate the usability and applicability of a self monitoring test of visual function with the handheld Health Management Tool (HMT) to remotely monitor neovascular Age Related Macular Degeneration (AMD) to detect a potential change in disease status.

Study Overview

• Status: Completed
• Conditions: Age Related Macular Degeneration (AMD)
• Intervention / Treatment: Other: Health Management Tool (HMT)

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90211
      • Novartis Investigative Site
    • Sacramento, California, United States, 95819
      • Novartis Investigative Site
    • Torrance, California, United States, 90503
      • Novartis Investigative Site
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Novartis Investigative Site
    • Largo, Florida, United States, 33770
      • Novartis Investigative Site
    • Sarasota, Florida, United States, 34239
      • Novartis Investigative Site
  • Illinois
    • Springfield, Illinois, United States, 62704
      • Novartis Investigative Site
  • Michigan
    • Williamsburg, Michigan, United States, 49690
      • Novartis Investigative Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Novartis Investigative Site
    • Omaha, Nebraska, United States, 68131
      • Novartis Investigative Site
  • Nevada
    • Las Vegas, Nevada, United States, 89144
      • Novartis Investigative Site
  • New Jersey
    • Toms River, New Jersey, United States, 08753
      • Novartis Investigative Site
  • New York
    • New York, New York, United States, 10021
      • Novartis Investigative Site
    • Rochester, New York, United States, 14620
      • Novartis Investigative Site
    • Slingerlands, New York, United States, 12159
      • Novartis Investigative Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Novartis Investigative Site
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Novartis Investigative Site
    • Cleveland, Ohio, United States, 44195
      • Novartis Investigative Site
  • Pennsylvania
    • West Mifflin, Pennsylvania, United States, 15122
      • Novartis Investigative Site
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Novartis Investigative Site
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Novartis Investigative Site
    • Nashville, Tennessee, United States, 37203
      • Novartis Investigative Site
  • Texas
    • San Antonio, Texas, United States, 78240
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with CNV secondary to AMD and not other causes in at least one eye identified by the investigator to be eligible for ranibizumab treatment
• Patients with a BCVA letter score in the study eye is 24 or better using an ETDRS chart measured at 4 meters distance

Exclusion Criteria:

• Patients with any concurrent ocular condition that may result in visual loss during the study
• Patients with past (within the prior 6 months) or current use of, or likely need for, systemic medications that are known to be toxic to the lens, retina, or optic nerve
• Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home Monitoring Test; Health management tool (HMT) for measuring vision impairment	Other: Health Management Tool (HMT); Mobile computing platform (ie HMT) which allows subjects to perform home monitoring tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Threshold value of handheld Health Management Tool (HMT) for choroidal neovascular AMD diagnosis at baseline	16 weeks
Identification of clinically relevant worsening of visual function in the home self testing mVT scores	baseline to 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of the handheld Health Management Tool (HMT) home self testing on the days of site visits and the mVT assessments performed during the site visits for absolute values		after 16 weeks
Correlation between the home deterioration signal and the monthly change in the handheld Health Management Tool (HMT) assessments performed during the site visits		after 16 weeks
Patient compliance and reliability of performing the home self testing using the handheld Health Management Tool (HMT)		after 16 weeks
Correlation between absolute values of the handheld Health Management Tool (HMT) and BCVA/ central retinal subfield thickness (CRST)		16 weeks
Correlation of the monthly changes in handheld Health Management Tool(HMT)to those of BCVA / OCT / Clinical examination		after 16 weeks
Correlation of diagnosis of choroidal neovascular AMD with BCVA/ central retinal subfield thickness	The disease diagnoses at baseline will be correlated to values of BCVA and CRST at baseline	baseline
Correlation of monthly changes observed with thein the investigator judgment (CJ-C) to BCVA / OCT / Clinical examination	Monthly changes in BCVA /OCT and clinical examination will be compared to clinical relevant changes as judged by the investigator on the CJC.	baseline to 16 weeks
Patient compliance with the signs and symptom questionnaire	The percentage of completed assessments of the signs & symptoms questionnaire on the HMT will be provided	baseline to 16 weeks
Patient satisfaction regarding the use of the HMT		16 weeks

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Collaborators: Carematix, VAS (Vital Art and Science)

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2011
• Primary Completion (Actual): November 30, 2011
• Study Completion (Actual): November 30, 2011

Study Registration Dates

• First Submitted: July 1, 2011
• First Submitted That Met QC Criteria: March 1, 2012
• First Posted (Estimate): March 2, 2012

Study Record Updates

• Last Update Posted (Actual): July 12, 2018
• Last Update Submitted That Met QC Criteria: July 10, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: AMD; ranibizumab; Choroidal Neovascularization; Age related Macular Degeneration; Best Corrected Visual Acuity; Health Management Tool; HMT; Investigator's Clinical Judgement of Change; Central Retinal Subfield Thickness; visual function self test
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: CRFB002A2407

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No